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A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who
are motivated to stop smoking.

- Females of non-childbearing potential (surgically sterilized or at least 2 years
postmenopausal) who are not nursing may be included.

- Subjects must have smoked an average of at least 10 cigarettes per day during the past
year and over the month prior to the screening visit, with no period of abstinence
greater than 3 months in the past year.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with clinically significant cardiovascular disease in the past 6 months.

- Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal
behavior or subjects considered to have serious suicidal ideation or suicidal behavior
within the past 12 months.

- Subjects having active suicidal ideation or behavior identified at Screen or Baseline.

- Subjects currently or within the past 12 months requiring treatment for depression.
Subjects with current or prior history of panic disorder, anxiety disorder, hostility
or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar
disorder.

NCT00741884
Pfizer
Withdrawn
A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

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[email protected]

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